Scope, timeframe, and how this was counted (as of 2026-03-04)

The request was interpreted as: U.S. FDA oncology regulatory actions in the past 5 years (i.e., roughly 2021–2026), limited to (a) original/new oncology approvals and (b) supplemental approvals/label expansions, where the FDA action was based on ORR (overall response rate) and the median duration of response (DoR) reported for the pivotal efficacy population was < 6 months.

Using the provided extracted FDA/label/review data, I counted only cases where:

• The regulatory action type is original/new approval or supplemental approval (label expansion) (not “unclear” unless the action is still clearly an FDA approval action in the dataset), and
• The approval is explicitly ORR-based (commonly Accelerated Approval language, but ORR-based actions can also occur in other contexts), and
• The median DoR is explicitly reported as a numeric value < 6 months for the primary efficacy population supporting that action.
  • If median DoR was NR/NE/not reached/not estimable, it was not counted as <6 months.
  • If only a subgroup (e.g., PR-only responders) had median DoR <6 months but the overall pivotal responder population did not, it was not counted.

FDA oncology approvals/label expansions (2021–2026) that meet the criteria (ORR-based; median DoR <6 months)

TRUSELTIQ (infigratinib phosphate) — original/new approval; Accelerated Approval

• Regulatory action: original/new approval; accelerated approval ^1129511218
• Indication (oncology): adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement ^11293033
• ORR (pivotal): 23.1% (95% CI: 15.6, 32.2) by blinded independent central review (BICR) per RECIST v1.1 in Study 2204 (Cohort 1, n=108) ^237111281126
• Median DoR: 5.03 months (<6 months: yes) ^23711128155
• Why it qualifies: This is a clear example of an ORR/DOR-based oncology approval where the median DoR is explicitly <6 months in the pivotal cohort.

ZEPZELCA (lurbinectedin) — original approval; Accelerated Approval

• Regulatory action: original approval; accelerated approval ¹⁵⁷
• ORR (pivotal): investigator-assessed ORR 35% (95% CI 26%, 45) ¹²⁶ and IRC-assessed ORR 30.5% (95% CI 22%, 40) per RECIST v1.1 ⁶³⁵
• Median DoR: 5.3 months (investigator) and 5.1 months (IRC) (<6 months: yes) ^15802358863
• Why it qualifies: The pivotal efficacy summaries explicitly report median DoR <6 months alongside ORR, consistent with an ORR/DOR-based accelerated approval package ¹⁵⁷.

XPOVIO (selinexor) — original approval; Accelerated Approval

• Regulatory action: original approval; accelerated approval ^116224222
• Indication (oncology): relapsed/refractory multiple myeloma in combination with dexamethasone after ≥4 prior therapies (triple-class refractory) ^113714161413
• ORR (pivotal STORM Part 2): 25.4% (95% CI 18.0%, 34.1%), assessed by IRC per IMWG 2016 ^7214101413
• Median DoR: 4.4 months (<6 months: yes) ^{114101409141321521415}
• Why it qualifies: This is an ORR-based accelerated approval in hematologic oncology with a median DoR clearly <6 months in the pivotal cohort.

MEKINIST (trametinib) — supplemental approval; Accelerated Approval (solid tumors with BRAF V600E)

• Regulatory action: supplemental approval; accelerated approval ^1431438
• Indication (oncology): in combination with dabrafenib for adult and pediatric patients ≥6 years with unresectable or metastatic solid tumors with BRAF V600E mutation who progressed after prior treatment and have no satisfactory alternatives; approved under accelerated approval based on ORR and DoR ^4311315
• ORR (pivotal METRIC trial): investigator-assessed ORR 22% (95% CI 17%, 28%), assessed per RECIST v1.1 ^219622022197 (IRC/independent review ORR also reported) ^22002202
• Median DoR: 5.5 months (95% CI 4.1, 5.9) (<6 months: yes) ^{28832881219721982882}
• Why it qualifies: The supplemental accelerated approval is explicitly tied to ORR/DoR, and the median DoR is reported as 5.5 months in the cited efficacy results ^{431131528832881219721982882}.

KRAZATI (adagrasib + cetuximab regimen in cited pivotal pooled analysis) — supplemental approval; pathway unclear in excerpts; ORR-based with median DoR <6 months

• Regulatory action: supplemental approval; approval pathway unclear in the provided excerpts ^494492493
• Indication (oncology): KRAS G12C-mutated locally advanced or metastatic NSCLC after ≥1 prior systemic therapy ^{1174817471746}
• ORR (pivotal pooled adagrasib+cetuximab): 34.0% (95% CI 24.6–44.5) by BICR per RECIST v1.1 ²⁵²⁴
• Median DoR: 5.8 months (<6 months: yes) ^25242522495
• Why it qualifies (with a caveat): The dataset contains a supplemental action with BICR ORR and median DoR 5.8 months ^25242522495, but the excerpts do not clearly label the action as Accelerated Approval vs regular approval ⁴⁹³⁴⁹². It still meets your endpoint/DoR filter.

What did not qualify (common reasons)

Median DoR not reached / not estimable

Many ORR-based oncology accelerated approvals report median DoR as NR/NE at the time of approval; these were not counted as “<6 months” by your criterion. Examples include:

• KEYTRUDA MSI‑H/dMMR solid tumors: median DoR not reached ^{2163287228712873287428772876}
• JEMPERLI dMMR endometrial cancer: median DoR not reached ^{2107290329052904}
• Multiple cell therapies and other accelerated approvals with NR/NE medians (e.g., KYMRIAH, LUNSUMIO, etc.) where the median was not reached in the pivotal responder set ^{13481449118825862587}.

Subgroup-only DoR <6 months (overall pivotal median not <6)

Some products show <6 months median DoR in a subgroup (e.g., PR-only responders), but the overall pivotal responder population median DoR is ≥6 months or NR/NE; these were excluded. For example:

• YESCARTA: PR-responder subgroup median DoR 2.1 months, but overall pivotal median DoR 9.2 months ^27462747.

Median DoR equals 6.0 months (not “less than” 6)

If the median DoR is exactly 6.0 months, it does not meet “<6 months.” Example:

• TECELRA: median DoR 6.0 months ¹⁸¹⁴.

Bottom line (from the provided dataset)

Within the dataset of U.S. FDA oncology actions from ~2021 onward, the approvals/label expansions that clearly match ORR-based decision-making with median DoR < 6 months in the pivotal efficacy population are:

• TRUSELTIQ (infigratinib) — original; accelerated approval; median DoR 5.03 months ^23711128155
• ZEPZELCA (lurbinectedin) — original; accelerated approval; median DoR 5.1–5.3 months ^15802358863
• XPOVIO (selinexor) — original; accelerated approval; median DoR 4.4 months ^{114101409141321521415}
• MEKINIST (trametinib) — supplemental; accelerated approval; median DoR 5.5 months ^{143143828832881219721982882}
• KRAZATI (adagrasib+cetuximab pooled pivotal analysis in excerpts) — supplemental; pathway unclear; median DoR 5.8 months ^25242522495

Implications for interpretation

A median DoR <6 months in an ORR-based approval package generally indicates that while a measurable tumor shrinkage signal exists, durability is limited in the studied population—often reflecting heavily pretreated disease, aggressive biology, or resistance mechanisms. In the FDA context, these profiles frequently align with Accelerated Approval frameworks where confirmatory evidence is expected to verify clinical benefit, though the dataset also includes at least one case where the approval pathway is not explicit in the excerpts despite ORR/DoR being central to the evidence package ⁴⁹³⁴⁹².

If you want, I can also (a) restrict strictly to actions explicitly labeled Accelerated Approval (which would exclude the “pathway unclear” case), or (b) expand to include oncology actions where DoR distributions (e.g., % with DoR ≥6 months) suggest short durability even when the median is NR/NE (but that would not match your “median DoR <6 months” requirement).